Specialist QA- US Remote

Initial Therapeutics, Inc.; Washington (District of Columbia); Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Specialist QA to join their mission of serving patients. In this vital role, you will provide quality assurance support, collaborating with various functional areas to ensure compliance and quality in the production of innovative medicines. The ideal candidate will have a strong background in quality systems and regulations, with excellent communication and project management skills. This position offers a unique opportunity to make a lasting impact on patients' lives while advancing your career in a collaborative and innovative environment.

Benefits

Competitive Benefits

Flexible Work Arrangements

Stock Incentives

Time-Off

Qualifications

• Experience in quality assurance within the pharmaceutical industry.
• Strong understanding of regulatory requirements and compliance.

Responsibilities

• Provide quality assurance support to the Product Quality organization.
• Collaborate with functional areas on quality systems and records.

Skills

Quality Assurance

Regulatory Compliance

Communication Skills

Project Management

Investigation Skills

Education

Doctorate Degree

Master's Degree

Bachelor's Degree

Associate's Degree

High School Diploma/GED

Tools

Veeva

Trackwise

Job description

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At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities they present, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Specialist QA

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities they present, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Role and Responsibilities

What you will do

Let's do this. Let's change the world. In this vital role, you will provide quality assurance support to the Product Quality organization as a subject matter expert of quality systems and records. You will collaborate within PQ and with diverse levels in functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality, and Process Development on projects, issue resolution, and investigations. The QA Specialist will use technical abilities and knowledge of QMS processes, procedures, and regulations to lead and deliver quality assurance responsibilities, including reviewing and approving Product Quality records and documentation such as product specifications, in-process control specifications, technical reports, annual product reviews (APRs), international expansion forms, change control records, data sheets, data analysis, deviation investigations, CAPAs, analytical comparability protocols and reports, and procedures. Additionally, this role will approve commercial variation records (GDCR) and may provide training to staff.

Responsibilities include:

• Executing transactions in GMP systems (Veeva CDOCs, Trackwise, etc.) and supporting business processes for APRs and site audits.
• Supporting management of products in the annual review cycles.
• Providing QA systems expertise within a team environment.
• Supporting QA tasks for clinical and commercial products, including document review and approval.
• Supporting audits/inspections, APR management, and continuous improvement initiatives.
• Interacting with various functional areas within Amgen.

Qualifications

What we expect of you

We value diverse contributions. The ideal candidate will have:

Basic Qualifications:

• Doctorate degree or
• Master's degree with 2 years of relevant experience or
• Bachelor's degree with 4 years of relevant experience or
• Associate's degree with 8 years of relevant experience or
• High school diploma/GED with 10 years of relevant experience.

Preferred Qualifications:

• Understanding of pharmaceutical sciences, quality, compliance, and regulatory requirements.
• Knowledge of biopharmaceutical manufacturing and QC testing.
• Experience with VEEVA, Trackwise, and other Amgen quality systems.
• Experience reviewing and approving cGMP documentation.
• Strong investigation and change control experience.
• Experience with Amgen variation management systems.
• Excellent communication, organizational, and project management skills, with ability to interact with senior management.

What you can expect from us

We support your professional and personal growth through competitive benefits, a collaborative culture, and opportunities for development. Compensation includes base salary, bonuses, stock incentives, time-off, and flexible work arrangements.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In your application materials, you may redact age-identifying information. Amgen does not have a specific application deadline; we will consider applications until the position is filled.

We are committed to diversity and inclusion and are an Equal Opportunity employer. We provide reasonable accommodations for applicants with disabilities.